# K971823: Active Testosterone Eia (DSL-10-4000)

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Systems Laboratories, Inc.
- Decided: Jun 16, 1997 after 31 days
- Product code: CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone)
- Device class: 1
- Regulation: 21 CFR 862.1680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) DSL Testosterone RIA: named in the summary without a submission number

## Most influential descendants
- K014120: Testosterone by Enzymeimmunoassay (Eia) (2002), 0 descendants of its own

## Indications for use
The DSL-10-4000 ACTIVE™ Testosterone Enzymeimmunoassay (EIA) Kit provides materials for the quantitative measurement of testosterone in serum. This assay is intended for in vitro diagnostic use. Measurement of testosterone is used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and in females hirsutism and virilization due to tumors, polycystic ovaries and adrenogenital syndrome.

Source page: https://510kreport.com/device/K971823
Methodology: https://510kreport.com/methodology